Neurodegenerative disease biomarkers based on high quality wireless EEG.

Información del proyecto

NEUMARQ

Identificador del acuerdo de subvención: 662975

DOI 10.3030/662975

Proyecto cerrado

Fecha de la firma de la CE 18 Diciembre 2014

Fecha de inicio 1 Enero 2015

Fecha de finalización 30 Junio 2015

Financiado con arreglo a

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coste total € 71 429,00

Aportación de la UE € 50 000,00

Coordinado por

STARLAB BARCELONA SL
Spain

Periodic Reporting for period 1 - NEUMARQ (Neurodegenerative disease biomarkers based on high quality wireless EEG.)

Período documentado: 2015-01-01 hasta 2015-06-30

Resumen del contexto y de los objetivos generales del proyecto

Today, although over 6M people suffer from Parkinson's and related diseases worldwide we have no objective early diagnostic test. By the time patients present the symptoms that lead to diagnosis the disease is already very advanced and the options for treatment extremely limited. This has an enormous impact on cost of care and an even greater impact on patient and carer quality of life. An early diagnostic test will revolutionise treatment in terms of slowing disease evolution and improved outcomes, with fewer years in the advanced phases of the disease requiring expensive full-time care. Taking the US as our model (available data) it is estimated that the economic impact in direct medical costs is over $6 billion annually and $11 billion including cost of care. Early detection means fewer years in fulltime care, which translates to savings of $50k per year per patient, which if we take a 10% reduction on the 30% of all patients in this phase we will see a $1.5 billion saving in the US alone.
Our goal:
We aim to commercialise non-invasive, very low-cost preclinical electroencephalograph (EEG) biomarkers for synucleinopathies (Parkinson Disease - PD and Lewy Body Dementia - LBD), which will have real impact on both quality of life and cost of care.
Treatment and indeed new treatment options for PD/LBD patients critically depend on the identification of at risk subjects, the characterization of their preclinical brain alterations, and the availability of very early follow-up/evolution criteria. EEG offers advantages as a marker of PD/LBD as it is a direct indicator of normal or altered brain activity, genetically controlled, non-invasive, can be repeated as many times as necessary, does not require active patient cooperation, and is very low cost.
Objectives:
O1 Clinical trial - Primary goal: We aim to validate our existing results through a multisite replication. Secondary goal: We aim to benchmark our approach against the competition as a diagnostic aid for symptomatic patients with a synucleinopathy.
O2 In depth market and risk analysis for business model development: This shall include an analysis of our assumptions on market size, segmentation, demand, barriers and competition. We shall also analyse the regulatory, reimbursement and stakeholder environments in each of our target countries. Several business models shall be explored using a business model canvas approach and the value proposition elaborated in order to provide requirements for the service design. In partnership with expert consultants we shall define a strategy for each country in our launch target tailored to local regulatory and reimbursement requirements, stakeholders and key opinion leaders.
O3 Define NEUMARQ service user requirements: Through an iterative, prototyping approach based on design thinking we shall define end user and patient requirements for NEUMARQ 0.1. The goal here is to unearth any issues that will potentially affect our business model while helping or stakeholders understand the finished service.
O4 Finalise and deliver a business plan based on the results of Phase 1: Our business plan shall be revised and improved based on the results of the work outlined in Objectives 1 through 3.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

As written in our original SME phase 1 proposal our goal is to commercialise non-invasive, very low-cost preclinical electroencephalograph (EEG) biomarkers for synucleinopathies (Parkinson Disease - PD and Lewy Body Dementia - LBD), which will have real impact on both quality of life and cost of care.

Phase 1 of this effort has involved:
1 a feasibility study
2 further technical validation of our biomarker
3 the launch of a pre-clinical multi-site validation of our initial results in partnership with the Michael J Fox Foundation and 7 hospitals around the world

During this process a lot has been learned, assumptions tested and advice evaluated. An important consequence of this is an updated workplan for NEUMARQ the SME project and an updated plan for NEUMARQ the product.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

As a result of this action we plan to implement a refined and much approved business plan. The next phase will be a clinical trial followed, if successful, by a European launch.

Starlab